Lithium ascorbate is known to be used as a constituent element in the composition exhibiting antioxidant and immunostimulating activity (RU No 2444358 C1, 10 Jan. 2012), as an agent for increasing neutrophil efficiency (RU 15 No 2226391 C2, 10 Jan. 2004), as a hematoprotective agent (RU No 22351326 10 Apr. 2009).
All the mentioned references about lithium ascorbate do not disclose or suggest its potential antidepressive, anxiolytic, and antistress properties. Analysis of the available prior art showed that no data on antidepressive, anxiolytic, or antistress activities of lithium ascorbate have been previously published by others.
There are currently in use lithium salt-based compositions with nootropic activity. There is currently in use a lithium salt n-(4-acetoxybenzoyl) glycine (RU 2505294, 27 Jan. 2014), which refers to new water-soluble lithium salts of glycine derivative (aminoacetic acid) with 4-hydroxybenzoic acid. The said agent enables to obtain a highly effective water-soluble glycine derivative and 4-hydroxybenzoic acid combining the main effects inherent to tranquilizing and nootropic agents.
From the data source (RU 2322240 C1, 20 Apr. 2008), there is a pharmaceutical composition possessing nootropic activity and comprising an active substance dimephosphon. The pharmaceutical in the form of aqueous solution contains additionally citric acid and lithium carbonate with the following ratio of the components, mass %: dimephosphon 15.0-30.0; lithium carbonate 0.5-5.0; citric acid 3.0-4.0; deionized water—up to 100. A shortcoming of the said composition is its considerable toxicity due to the usage of the lithium salt (lithium carbonate) possessing high toxicity.
There also exists a preparation (known from patent RU 2428992 C1, 20 Sep. 2011) for correcting stress conditions in livestock comprising lithium oxybate, sodium selenite, ascorbic acid and water for injections in the ratio of the components (in mass %): lithium oxybate—4.0-7.0; sodium selenite—0.2-0.5; ascorbic acid—3.0-12.0; water for injections—the rest. The preparation possesses a marked nootropic activity and immunostimulating action, and is convenient for administration. A shortcoming of the said composition is usage of lithium oxybate having a variety of side effects such as general malaise, dizziness, drowsiness, muscle weakness, tremor of the upper extremities, sinus tachycardia, dyspeptic events, diarrhea, tremor, tic, development of diffuse nontoxic goiter, allergic reactions.
A lithium salt of comenic acid and usage thereof as antioxidant and stress- and neuroprotective agent is known from the patent (RU 2477722 C1, 20 Mar. 2013). It follows from the said patent that (RU 2477722 C1, 20 Mar. 2013) that a lithium salt of comenic acid is obtained by mixing a comenic acid solution, heated to the temperature of 80±2° C., with the stoichiometric amount of the solution of carbonate or lithium hydroxide and coloring the solution in yellow and a pH value of the solution of 4.6 or 10.0, respectively, and isolating the lithium salt of comenic acid from the solution by distilling off the water under vacuum. A lithium salt of comenic acid belongs to the agents for the prevention and treatment of neurodegenerative diseases caused by oxidative damage of the brain. For this purpose, a lithium salt of lithium comenic acid is proposed to be taken in the amount of 2 mg per 1 kg of body weight once daily for 3 days. A disadvantage of this invention is that it is aimed only at the prevention and treatment of neurodegenerative diseases caused by oxidative brain damage.
There is a lithium-containing agent for the prevention and treatment of cerebrovascular diseases (RU 2367427 C1, 20 Sep. 2009). The mentioned agent for the treatment and prevention of cerebrovascular diseases contains a lithium salt where the lithium cation is bound to the anion of an organic acid from a group of the following: adipate, aspartate, benzoate, gamma linolenoate, glycinate, gluconate, nicotinate, orotate, salicylate, citrate. The lithium-containing agent for the prevention and treatment of cerebrovascular diseases ensures the efficiency of treatment at low doses of the indicated agent. However, this agent is aimed only at the prevention and treatment of stroke.
The closest to the claimed composition is an agent containing lithium carbonate used as a medicine by patients in a manic phase and for the prevention of exacerbation of bipolar affective disorders, schizoaffective disorders, manic conditions of various genesis, affective disorders in chronic alcoholism, drug dependence, sexual abnormalities, Meniere's syndrome, migraine [M. D. Mashkovsky, Lekarstvenniye Sredstva: Posobiye dlya vrachei.-T.1.-Moscow: Novaya Volna.-2002.-p. 109-110]. The main shortcoming of this agent is low bioavailability that results in the need for high dosages, as well as high toxicity (LD50=531 mg/kg), which leads to numerous side effects: tremor, drowsiness, adynamia, cardiac rhythm disturbance, myasthenia gravis, increased thirst, polyuria and renal dysfunction. This considerably narrows the therapeutic range, with a high risk of overdose.